FDA spokeswoman Stephanie Kakumo declined to provide details. “While we cannot comment on individual interactions with sponsors, we generally work with sponsors to ensure the number of clinical trial participants is sized appropriately to detect safety signals,” she said in an email.
In June, the Centers for Disease Control and Prevention Published data It shows that the two vaccines may cause myocarditis and pericarditis in more than 1,200 Americans, including about 500 of those under the age of 30. Symptoms usually appeared within two weeks and were more common in young men and boys. The rate was low: fewer than 13 cases per million doses administered.
Understand the state of vaccine mandates in the United States
Most cases were mild and recovered quickly, the researchers said. Dr. Paul A. Offit, an infectious disease specialist who previously served on the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee, which makes recommendations for vaccine use in the United States, noted that infection with the coronavirus also poses risks.
He said that if expanding trials were to cause delays in allowing the use of vaccines for children, that would also put children at risk. “There is always a human price to pay for knowledge,” he said. He said of heart disease, “It is rare, generally short-lived and self-healing. It is also the result of a natural infection.”
CDC data showed 12.6 cases per million second doses, and researchers estimated that out of one million second doses given to boys aged 12 to 17, the vaccines might cause a maximum of 70 cases of myocarditis, but would prevent 5,700 infections. With the virus, 215 cases were hospitalized. And two deaths. Covid-19 itself may cause heart problems in young people.
The U.S. Food and Drug Administration approved the Pfizer vaccine on an emergency basis for children ages 12 to 15 in April. So far, the Moderna vaccine has only been approved for people 18 years of age or older. The agency included a warning about possible heart problems in its Vaccines Fact Sheets in June.
Many public health experts argue that with so much attention focused on hospitalization and deaths among older Americans with coronavirus, the risk to children has been overlooked. the Reported by the American Academy of Pediatrics Last week, more than four million American children and teens tested positive for the virus and 346 died since the pandemic began.
Biden’s attempt to set a public timeline for a possible mandate for children under 12 was unusual, and he risked setting expectations for regulators to resolve a highly sensitive issue too soon. Biden and members of his administration have said they do not want to interfere or be seen as affecting the work of regulators at the Food and Drug Administration — something former President Donald J. Trump tried repeatedly last year during the agency’s review of coronavirus drugs. and vaccines.
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